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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceST. JUDE MEDICAL MECHANICAL HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS054
Date Received09/27/2000
Decision Date10/23/2000
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE AORTIC POLYESTER CUFF CONFIGURATION OF THE SJM(R) MASTER SERIES HP VALVE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SJM(R) MASTER SERIES HEMODYNAMIC PLUS (HP) WITH FLEX CUFF(TM), MODEL AFHPJ-505, AVAILABLE IN AORTIC SIZES 17, 19, 21, 23, 25, AND 27 MM.
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